Job Description

Position: Senior Medical Writer

Location: San Rafael, CA, Hybrid (1-2 days in office to align with company policy).

Duration: 12+ Months Contract

Role Description

Seeking candidates who are regulatory medical writers (not Medical Communication)

EDUCATION & SKILLS:

• Bachelor’s or higher degree; scientific focus desirable.
• Evidence of medical writing career development is desirable, e.g., American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through the Drug Information Association.
• At least 6+ years of experience required

Fulfills one of the following:

• Medical writer in the pharmaceutical industry
• Medical or scientific writing experience as a primary job responsibility

Key Responsibilities

• Drafts and edits documents used for submissions including CTDs and RtQs
• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)

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